Scientific development and innovation are the lever for a better and fairer world. In the area of health, it is very important that access to health care and diagnostics is accessible to all people, in particular to those who, due to geographical circumstances, are less favored. Scientists and academics must make their knowledge available to companies and society in general.
This is the meaning of our work at Cespu Diagnóstico, through technological innovation, with the introduction of new technological tools, at the service of global health.
Cespu Diagnóstico, S.A., is a Portuguese company of the CESPU Group, a Higher Education Institution that has been training highly qualified health professionals for over 40 years. In 2012, the notoriety of the research produced in the pathological anatomy and cytology field led to the creation of a startup of the Cespu Group (Targetalent), which was later renamed to Cespu Diagnóstico, with the objective of introducing a disruptive technology for the staining of cytology samples in the market.
Its core business is the research, production, and marketing of in vitro diagnostic medical devices.
The Bluestain® project resulted from the need to materialize a research project with a business vocation. Its purpose is to promote point-of-care diagnostic solutions and provide simplified diagnostic processes that can reach the entire population, with high-quality standards guaranteed by scientific validation by experts in the field.
Cespu Diagnóstico owns another CE-marked in vitro diagnostic medical device consisting of a viral medium kit that allows the collection, transport, and preservation of saliva samples for the diagnosis of SARS-CoV2 by the molecular biology method (RT-PCR).
As a multi-award-winner in the research area, we intend to affirm ourselves as an innovative and differentiated company in the national and international markets.
The research developed by Cespu Diagnóstico is certified by SGS as part of the Research Management System according to standard NP 4457 – Management of Research, Development, and Innovation. For the design, development, and manufacture of medical devices, Cespu Diagnostics uses the NP EN ISO 13485 – Medical devices, management systems, regulatory requirements standard as a reference.
In a recent article from Jennifer Kane et al, “a systemic review of Primary Care Models for non-communicable Disease Interventions in Sub-Saharan Africa”, we verified that chronic diseases like cardiovascular disease, respiratory disease, diabetes, and cancer, are the leading causes of death and disability worldwide. Rates of non-communicable disease are rapidly rising and evidence of primary healthcare approaches is needed. As we can learn, diagnostic tools and medications at local primary healthcare clinics and the use of standardized protocols for diagnosis, treatment, monitoring, and referral to specialist care.
Early diagnosis offers a window of opportunity for interventions that enable treatment in an asymptomatic and modifiable phase of the disease, increasing the probability of survival.
The traditional screening method is based on performing cytology and its use in organized screening programs was the main contribution to the large reduction in mortality from cervical cancer in many countries. Several studies carried out over the years have concluded that cytology has, on average, a sensitivity and specificity between 30-80% and 86-100%, respectively.
Cytology is the method by which a collection of cells from the cervix is carried out, with the aim of identifying cellular abnormalities in the transformation zone. This is the main region where dysplastic and neoplastic changes occur, which makes it necessary to collect a good sample from this region. Materials such as spatulas and/or brushes can be used to carry out this collection, and subsequently the method of processing the sample is variable and can be extended on a glass slide or dispersed in a liquid fixative medium.
BlueStain® is an in vitro diagnostic medical device that meets high-quality standards. Is a reliable clinical tool for the evaluation of the suitability, screening, and preliminary diagnosis of a variety of cytology specimens.
Its application optimizes resource usage and puts the device at the disposal of all forms of screenable cancer through cytology.
This staining method has also overcome the difficulty, or even impossibility, of applying conventional staining techniques in geographically remote locations with scarce human and/or financial resources. In many countries around the world, cytology-based screening or diagnosis is not possible, or when it exists, it offers very late results and very low clinical accuracy. With BlueStain® we want to turn this around and therefore put people at the center of our scientific research.
Coupled with the swiftness and innovation of staining, it is possible to explore digital pathology through scanning equipment, transforming slides into digital cytology, which will allow diagnosis, remotely, anywhere in the world by pathologists.
This in vitro diagnostic medical device meets the performance requirements for in vitro diagnostic use under Regulation (EU) 2017/746 and is CE-marked. Cespu Diagnostic researchers already have a published article in Acta Cytologica with scientific evidence about the BlueStain® and it’s potential.
The BlueStain® method consists of cytoplasmic and nuclear staining, which can be performed in just 2 minutes, allowing:
- Definition of nuclear details, providing a perfect analysis of inflammatory and neoplastic changes.
- Cytoplasmic transparency is of particular importance because of the different cell thicknesses and frequent cell overlap in the sample.
Meeting quality requirements, short staining time, and ease of use are advantages of this new stain. Exposure to hazardous chemicals is minimized compared to other staining agents since only one solvent is used. Furthermore, BlueStain® is more economical compared to other commercial dyes in clinical practice, as it requires less manpower and reagents. This innovation in sustainability will enable higher lab productivity, without compromising stain quality and lowering the cost per slide.
In our research team, we are also committed to the environment and mental health. In these areas, with BlueStain® technology we achieved a strong reduction in the use of chemicals, as well as a significant improvement in the environmental footprint, compared to traditional techniques. In addition, we developed a well-being and mental health screening tool, using an innovative algorithm, which quickly evaluates, monitors, and provides feedback in real-time. We are focused on point-of-care technologies, in a disruptive way and absolutely committed to the environment and mental health. At Cespu Diagnostic we approach the research and development process with a focus on health in its broadest concept of complete physical, mental, and social well-being.